PharmacokineticsPhase 1NCT03324061
Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration
A Phase 1 study testing Fulvestrant for Injectable Suspension and Faslodex (Reference) in people with Pharmacokinetics, run by Eagle Pharmaceuticals, Inc. at 12 sites in United States.
Trial summary
Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product, Faslodex in healthy female subjects. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Fulvestrant for Injectable Suspension and Faslodex (Reference)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 12 sitesUnited States
- Study dates
- 30 Nov 2017to 12 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) of 18 kg/m2 to 32 kg/m2
- Body weight of at least 50 kg at screening
- Good health as determined by evaluations
- Negative serum pregnancy test
- Subjects who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating hormone level at Screening of ≥40 mIU/mL
- Subjects who are peri-menopausal and experiencing at least one of specified symptoms of menopause (eg, hot flashes, mood swings, night sweats, and others)
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- Negative urine test for drugs of abuse
- Negative urine test for HIV antibody, HBsAG, and HCV at Screening
- Women of child-bearing potential must agree to consistently practice contraception throughout the duration of the study and continue to do so for 1 year after receiving study drug by one of the following methods: abstinence, condom, diaphragm or cervical cap with spermicide, intrauterine device or male partner had previously undergone a vasectomy as declared in medical history
Who cannot join
- Recent history (6 months) or current evidence of any clinically significant (uncontrolled) disorder including hepatic, renal, cardiovascular, psychological, pulmonary, metabolic, endocrine, neurologic, infectious, gastrointestinal, hematologic or oncologic disease, or other medical conditions that may interfere with the subject completing the study
- Lab test results outside the normal range at Screening or Day 1 considered clinically significant by the Investigator
- Use of hormonal replacement therapy within 6 months prior to randomization an/or current use of oral contraceptive pill or patch as contraceptive method throughout the study
- Concomitant medication that can affect bleeding
- Recent history (6 months) or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant
- Subjects with QTcF interval duration >470 milliseconds
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- History of alcoholism or drug addiction within 1 year prior to Day 1
- History of allergy or a known sensitivity to product components of fulvestrant Test and Reference formulations
- Creatinine clearance <60 mL/minute based on the Cockcroft-Gault equation
- Blood donation of 500 mL or more or a significant loss of blood within 56 days prior to Day 1
- Previous exposure to fulvestrant
- Familial relationship with another study participant
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Optimal Research, LLC
Austin, Texas, 78705
Hassman Research Institute
Berlin, New Jersey, 08009
New Horizon Clinical Research
Cincinnati, Ohio, 45242
Avail Clinical Research, LLC
DeLand, Florida, 32720
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Clinical Research Consortium
Las Vegas, Nevada, 89119
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
Quotient Sciences
Miami, Florida, 33126
Advanced Pharma CR, LLC
Miami, Florida, 33147
Orlando Clinical Research Center
Orlando, Florida, 32809
Worldwide Clinical Trials
San Antonio, Texas, 78217
About this study
Official title: A Phase 1, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fulvestrant (Test vs. Reference) Following Intramuscular Administration to the Gluteal Muscle in Healthy Female Subjects
Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product, Faslodex in healthy female subjects.
Read the detailed description
This is a Phase 1, open-label, parallel group study in healthy female subjects. The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of Fulvestrant for Injectable Suspension vs. the reference drug, Faslodex, administered in the gluteal muscle.
- Conditions
- Pharmacokinetics
- Being tested
- Fulvestrant for Injectable Suspension, Faslodex (Reference)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fulvestrant for Injectable SuspensionDrug
Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
Faslodex (Reference)Drug
Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant for Injectable Suspension | Experimental | Fulvestrant for Injectable Suspension (500 mg/vial) Receives: Drug: Fulvestrant for Injectable Suspension |
| Faslodex (R) | Active comparator | Faslodex (250 mg/mL) Receives: Drug: Faslodex (Reference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Area under the concentration-time curve(AUC)
Measured: Day 0 through Day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start30 Nov 2017
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eagle Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian J Hepner, MD, PhD, Study director, Eagle Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324061
- Sponsor's protocol ID
- EGL-5835-C-1701
- Status last verified
- Jun 2021
- First submitted
- 24 Oct 2017
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fulvestrant (Test vs. Reference) Following Intramuscular Administration to the Gluteal Muscle in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT03324061
- Acronym / sponsor ID
- EGL-5835-C-1701
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Eagle Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product, Faslodex in healthy female subjects.
Detailed description
This is a Phase 1, open-label, parallel group study in healthy female subjects. The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of Fulvestrant for Injectable Suspension vs. the reference drug, Faslodex, administered in the gluteal muscle.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant for Injectable Suspension | Experimental | Drug: Fulvestrant for Injectable SuspensionFulvestrant for Injectable Suspension (500 mg/vial) |
| Faslodex (R) | Active comparator | Drug: Faslodex (Reference)Faslodex (250 mg/mL) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body Mass Index (BMI) of 18 kg/m2 to 32 kg/m2
- Body weight of at least 50 kg at screening
- Good health as determined by evaluations
- Negative serum pregnancy test
- Subjects who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating hormone level at Screening of ≥40 mIU/mL
Key exclusion criteria (12 listed)
- Recent history (6 months) or current evidence of any clinically significant (uncontrolled) disorder including hepatic, renal, cardiovascular, psychological, pulmonary, metabolic, endocrine, neurologic, infectious, gastrointestinal, hematologic or oncologic disease, or other medical conditions that may interfere with the subject completing the study
- Lab test results outside the normal range at Screening or Day 1 considered clinically significant by the Investigator
- Use of hormonal replacement therapy within 6 months prior to randomization an/or current use of oral contraceptive pill or patch as contraceptive method throughout the study
- Concomitant medication that can affect bleeding
- Recent history (6 months) or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fulvestrant for Injectable SuspensionTest drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area | Drug | Fulvestrant for Injectable Suspension |
| Faslodex (Reference)Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas | Drug | Faslodex (R) |
Primary outcome
Pharmacokinetic parameters
Time frame: Day 0 through Day 140
Area under the concentration-time curve(AUC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian J Hepner, MD, PhD study director
Eagle Pharmaceuticals, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fulvestrant for Injectable Suspension and Faslodex (Reference) in people with Pharmacokinetics, run by Eagle Pharmaceuticals, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters (time frame: Day 0 through Day 140). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.